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A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)

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Trial Profile

A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Oct 2023

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At a glance

  • Drugs Vipoglanstat (Primary) ; Celecoxib
  • Indications Systemic scleroderma; Vascular disorders
  • Focus Adverse reactions; First in man
  • Sponsors Gesynta Pharma

    • Most Recent Events

    • 06 Jun 2020 Eight subjects were treated in a separate cohort with 200mg celecoxib bid for ten days, according to results presented at the 21st Annual Congress of the European League Against Rheumatism
    • 06 Jun 2020 Results of mPGES-1 activity (Ex vivo) for 24 hours assessing content of PGE2 and PGI2 metabolites in urine in all cohorts and in an additional celecoxib cohort and all presented at the 21st Annual Congress of the European League Against Rheumatism
    • 15 May 2020 Results presented in the Orexo Media Release.

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